AiSuTe (tegileridine) / Jiangsu Hengrui Pharma - LARVOL DELTA

Tegileridine for Postoperative Pain Management in Abdominal Surgery: A Randomized, Double-Blind, Phase 3 Clinical Trial (ASA 2025) - "Abstract is embargoed at this time."

Clinical • P3 data • Surgery • Pain

Exploring Pharmacokinetic interactions between SHR8554, a µ-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. (PubMed, Sci Rep) - P1 | "Therefore, when co-administered with CYP3A4 inhibitors, SHR8554 maintained its distinctive PK profile while the subjects experienced an increase in symptoms associated with opioid receptor activation. The ClinicalTrials.gov identifier is NCT05928988 (03/07/2023)."

Journal • PK/PD data • Pain

The Impact of Tegileridine Fumarate Injection on Postoperative Urinary Retention Following Laparoscopic Hernia Repair in Elderly Patients: A Double-Blind, Randomized, Controlled Trial (ChiCTR) - P=N/A | N=220 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Shantou University Medical College; The First Affiliated Hospital of Shantou University Medical College

New trial • Gastroenterology

Efficacy and safety of SHR8554 on postoperative pain in Thoracoscopic Lung Surgery (ChiCTR) - P=N/A | N=256 | Not yet recruiting | Sponsor: The First People’s Hospital of Lianyungang; The First People’s Hospital of Lianyungang

New trial • Pain

Evaluation of the clinical effect of tegileridine fumarate injection for postoperative analgesia after video-assisted thoracoscopic surgery: a single-center, randomized, double-blind, positive controlled study (ChiCTR) - P=N/A | N=114 | Not yet recruiting | Sponsor: Chengdu Second People’s Hospital; Chengdu Second People’s Hospital

New trial • Pulmonary Disease • Respiratory Diseases

Study on the effective dose of tegileridine combined with propofol in hysteroscopic surgery (ChiCTR) - P=N/A | N=45 | Not yet recruiting | Sponsor: Lianyungang Maternal and Child Health Hospital; Lianyungang Maternal And Child Health Hospital

New trial • Gynecology

Hengrui's innovative drug Tegileridine Fumarate Injection is approved for the treatment of moderate to severe postoperative pain [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine received the 'Drug Registration Certificate' approved and issued by the National Medical Products Administration, approving the company's Class 1 innovative drug, China's first independently developed biased μ opioid receptor agonist, tegileridine fumarate Injection (trade name: Aisut) to add an indication, and the new indication is 'for the treatment of moderate to severe pain after orthopedic surgery.' The National Medical Products Administration agreed to merge this new indication with the previously approved indication for abdominal postoperative pain into 'This product is used to treat moderate to severe postoperative pain.' This means that the product will provide a new treatment option for more patients with postoperative pain."

China approval • Pain

Efficacy and safety of SHR8554 on postoperative pain in subjects with moderate to severe acute pain following orthopedic surgery: A multicenter, randomized, double-blind, dose-explored, active-controlled, phase II/III clinical trial. (PubMed, Pharmacol Res) - "In conclusion, SHR8554 exhibited efficacy compared to placebo and safety comparable to morphine for patients experiencing moderate-to-severe acute pain following unilateral total knee replacement or knee ligament reconstruction surgery. TRIAL REGISTRATION: Trial Name: Study on the Efficacy and Safety of SHR8554 Injection for Postoperative Analgesia in Orthopedics: Multicenter, Randomized, Double Blind, Dose Exploration, Placebo/Positive Control, Phase II/III Clinical Trial Registered on: chinadrugtrials.org.cn Identifier: CTR20220639."

Clinical • Journal • P2/3 data • Musculoskeletal Diseases • Orthopedics • Pain • ARRB1

To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain (clinicaltrials.gov) - P4 | N=75 | Completed | Sponsor: Yuwei Qiu | Not yet recruiting ➔ Completed

Trial completion • Pain

A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2/3 | N=320 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Surgery • Trial completion • Musculoskeletal Pain • Orthopedics • Pain

A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2/3 | N=320 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Surgery • Musculoskeletal Pain • Orthopedics • Pain

Study of the mass balance, biotransformation and safety of [C]SHR8554, a novel μ-opioid receptor injection, in healthy Chinese subjects. (PubMed, Front Pharmacol) - "The main excretion route of SHR8554 and its metabolites is through urine. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/, identifier CTR20220450."

Journal • Gastrointestinal Disorder • Pain • ARRB1

A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial

A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2/3 | N=320 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P2 ➔ P2/3 | N=120 ➔ 320 | Trial completion date: Oct 2022 ➔ Dec 2023 | Trial primary completion date: Oct 2022 ➔ Dec 2023

Enrollment change • Enrollment open • Phase classification • Surgery • Trial completion date • Trial primary completion date • Musculoskeletal Pain • Orthopedics • Pain

A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery. (clinicaltrials.gov) - P2 | N=108 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Pain

A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery. (clinicaltrials.gov) - P3 | N=528 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Enrolling by invitation ➔ Completed

Trial completion • Pain

A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Musculoskeletal Pain • Orthopedics • Pain

A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery. (clinicaltrials.gov) - P3; N=528; Enrolling by invitation; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Enrolling by invitation; Phase classification: P2b/3 ➔ P3; N=192 ➔ 528; Trial completion date: Jul 2021 ➔ Dec 2021

Clinical • Enrollment change • Enrollment open • Phase classification • Trial completion date • Pain

A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2/3; N=192; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Pain • Orthopedics • Pain

A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2/3; N=192; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P2/3 trial • Musculoskeletal Pain • Orthopedics • Pain